Module 9 2021

For biologicals in particular

• The clinical development of biologicals and its regulation has a variety of product specific aspects which need to be carefully navigated

• Remember that the majority of technical guidance relates to standards required for product approval (this is changing), not for clinical investigation

• It is necessary to summarise clear quality and preclinical safety information for clinical trial regulators in order to address the critical benefit risk evaluation, particularly for FIM studies.

Clinical Development of Biopharmaceuticals Tara Hutton

The Organisation for Professionals in Regulatory Affairs

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For biologicals in particular

• Safety testing of biologicals is inevitably complicated by the common mismatch between test article specificity, selection of test species, dose, route of administration, duration of exposure, immunogenicity and so on • Another perfect example of the case by case basis applies here in a situation where guidance can really only aim to be indicative rather than definitive

Preclinical Testing of Biologicals Alison Wollfreys

The Organisation for Professionals in Regulatory Affairs

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